BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2162418 · Received July 14, 2011

    Report

    Report Number
    3002648230-2011-00080
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED ISSUE WAS CONFIRMED THROUGH TESTING; THE AIR ASPIRATION WAS REPRODUCED WHEN A CATHETER WAS INTRODUCED THROUGH THE SHEATH. DISSECTION SHOWED A LEAKING HEMOSTATIC VALVE. A FIELD ACTION WAS INITIATED IN JULY 2011 TO COMMUNICATE TO PHYSICIANS AND REGULATORY AUTHORITIES THIS POTENTIAL LEAK IN HEMOSTATIC VALVE OF MEDTRONIC CRYOCATH FLEXCATH 12 STEERABLE SHEATHS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN ANALYZED. RESULTS OF EVALUATION OF RETURNED DEVICE WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE ARCTIC FRONT CATHETER WAS INSERTED INTO THE FLEXCATH STEERABLE SHEATH. DURING ASPIRATION, AIR WAS COMING OUT OF THE FLEXCATH SHEATH. THE PHYSICIAN REPLACED THE ARCTIC FRONT CATHETER AND THE FLEXCATH STEERABLE SHEATH AND THE SAME PROBLEM OCCURRED. THE CRYOABLATION PROCEDURE WAS NOT PERFORMED; RF PROCEDURE WAS USED INSTEAD. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12 23511

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR